Venkatesh Biyya

This Project is a Phase 3 randomized, double-blind, placebo-controlled study of drug administered locally twice daily for three consecutive days for the prevention of Borreliosis in subjects bitten by a tick.

Roles & Responsibilities Reviewed the Protocols, CRF’s etc.,
Acquired knowledge in Clinical Trial terminology, Good understanding of Clinical Trial Phases, clinical protocols/ CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, CDISC, MedDRA, 21 CFR PART 11
Data step programming with SAS functions mainly INPUT, PUT, SUBSTR, INDEX, SCAN, SET, MERGE, and BY processing for data manipulations and calculations used in Clinical Data Management process.
Developed safety tables including Demographic table, Adverse Events table, and Concomitant Medication tables.

Project 1 Multi focal motor Neuropathy.
Client’s Name